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510(k) K103735

MEDILED MINI by Medix I.C.S.A. — Product Code LBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2011
Date Received
December 22, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Neonatal Phototherapy
Device Class
Class II
Regulation Number
880.5700
Review Panel
HO
Submission Type

Other clearances by Medix I.C.S.A.

  • K083179 — MEDILED PHOTOTHERAPY LAMP (February 27, 2009)
  • K070291 — MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX (September 21, 2007)
  • K931529 — INFANT WARMER (March 11, 1994)
  • K931965 — MEDIX PHOTOTHERAPY LAMP (December 9, 1993)
  • K920049 — MEDIX PC-305 NEONATAL INCUBATOR (May 21, 1993)

Other clearances for product code LBI

  • K251308 — SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) (January 15, 2026)
  • K243372 — BiliWrap (May 29, 2025)
  • K210289 — Infant Phototherapy Equipment (May 28, 2021)
  • K200031 — Neonatal Phototherapy System (October 5, 2020)
  • K190899 — bili-hut (September 5, 2019)
  • K182178 — neoBLUE blanket LED Phototherapy System (December 13, 2018)
  • K172656 — BiliLux (May 1, 2018)
  • K170585 — Skylife (October 27, 2017)
  • K163526 — Bilicocoon™ Phototherapy System (October 6, 2017)
  • K160745 — neoBLUE compact LED Phototherapy System (December 12, 2016)